Cook G17013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002170131), received between Jul 1, 2022 and Jul 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2022Difficult to Open or Close; Difficult to Open or Close

  AS REPORTED, DURING A BI-LATERAL URETEROSCOPY (URS), A TOTAL OF FOUR NCIRCLE TIPLESS STONE EXTRACTORS FROM THREE DIFFERENT LOT NUMBERS WERE USED. WHEN THE FIRST EXTRACTOR WAS OPENED, ONLY TWO WIRES DEPLOYED AND THEY WERE UNABLE TO GRAB THE STONE. THE NEXT TWO EXTRACTORS, THE HANDLE MOVED AS NORMAL BUT NO BASKET DEPLOYED AT ALL. THE FOURTH EXTRACTOR WORKED PROPERLY AND THEY WERE ABLE TO EXTRACT THE STONE. IT IS UNKNOWN WHICH LOT NUMBER IS ASSOCIATED WITH ANY OF THE DEVICES USED. REFERENCE PATIENT IDENTIFIERS (B)(6) AND (B)(6) FOR THE OTHER TWO LOT NUMBERS USED. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885976 ↗